Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-001909-77
    Sponsor's Protocol Code Number:VAC18193RSV3006
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-001909-77
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Adults Aged 18 to 59Years, Including Those at High-risk for Severe RSV
    Ensayo en fase 3, Aleatorizado, Doble-ciego, controlado con placebo para evaluar la Seguridad e Inmunogenicidad de la vacuna Ad26.RSV.preF en adultos de 18 a 59 años de edad, incluyendo aquellos con alto riesgo de VRS severo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RSV Vaccine Phase 3 study for participants aged 18 to 59 years
    Estudio de fase 3 de la vacuna contra el VRS para participantes de 18 a 59 años.
    A.4.1Sponsor's protocol code numberVAC18193RSV3006
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Vaccines & Prevention B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Vaccines & Prevention B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG, S.A.
    B.5.2Functional name of contact pointGLOBAL CLÍNICAL OPERATIONS
    B.5.3 Address:
    B.5.3.1Street AddressPº de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917228100
    B.5.5Fax number0034917228628
    B.5.6E-mailbpiney1@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAd26.RSV.preF-based Vaccine
    D.3.2Product code VAC18193
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeJNJ-64400141
    D.3.9.4EV Substance CodeSUB187098
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeJNJ-64213175
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of Lower Respiratory Tract Disease Caused by The respiratory
    syncytial virus (RSV)
    Prevención de las enfermedades del tracto respiratorio inferior causadas por el virus respiratorio sincitial (VRS).
    E.1.1.1Medical condition in easily understood language
    Prevention of Lower Respiratory Tract Disease Caused by RSV
    Prevención de las enfermedades del tracto respiratorio inferior causadas por el VRS
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10039247
    E.1.2Term RSV infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the safety and reactogenicity of Ad26.RSV.preF-based RSV vaccine in healthy adults aged 18 to 59 years
    2. To assess the safety and reactogenicity of Ad26.RSV.preF-based RSV vaccine in adults aged 18 to 59 years at high-risk of severe RSV disease
    3. To demonstrate the non-inferiority of the humoral response to the administration of Ad26.RSV.preF-based vaccine in adults aged 18 to 59 years versus in adults aged 65 years and older
    4. If non-inferiority is demonstrated in adults: To demonstrate the non-inferiority of the humoral response to the administration of Ad26.RSV.preF-based vaccine in high-risk adults aged 18 to 59 years versus in adults aged 65 years and older
    1. Evaluar la seguridad y reactogenicidad de la vacuna contra el VRS basada en Ad26.RSV.preF en adultos sanos de 18 a 59 años.
    2. Evaluar la seguridad y la reactogenicidad de la vacuna contra el VRS basada en Ad26.RSV.preF en adultos de 18 a 59 años con alto riesgo de enfermedad grave por VRS.
    3. Demostrar la no inferioridad de la respuesta humoral a la administración de la vacuna basada en Ad26.RSV.preF en adultos de 18 a 59 años frente a adultos de 65 años en adelante.
    4. Si se demuestra la no inferioridad en adultos: Demostrar la no inferioridad de la respuesta humoral a la administración de la vacuna basada en Ad26.RSV.preF en adultos de 18 a 59 años con alto riesgo frente a adultos de 65 años en adelante.
    E.2.2Secondary objectives of the trial
    1. Investigate the vaccine-induced immune responses post-vaccination
    2. To assess the seroresponse rate postvaccination in the Immuno Subset
    1. Investigar las respuestas inmunitarias inducidas por la vacuna después de la vacunación.
    2. Evaluar la tasa de respuesta serológica después de la vacunación en el subconjunto de inmunogenicidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants above the age of 18 years in stable health at the time of vaccination, according to the investigator's judgement.
    - Female participants must be either
    a. not of childbearing potential or
    b. of childbearing potential and practicing an acceptable effective method of contraception and agrees to remain on such a method of contraception from signing the ICF until 3 months after study vaccination, and have a negative pregnancy test immediately prior to study vaccination.

    For Cohort 1 only:
    -participant is aged 18 to 59 years (inclusive) on the day of signing the ICF

    For Cohort 2 only (18-59 years):
    -participant is aged 18 to 59 years (inclusive) on the day of signing the ICF
    - has an existing chronic heart or lung condition, without hospitalizations or major medication class change (ie, new or stopped medications) within 30 days prior to screening, meeting the following criteria (based on Falsey et al. [2005]):
    a. Cardiac disease: at least Class II symptoms per New York Heart Association classification
    b. Pulmonary disease: activity-restricting symptoms or use of long-term medications.
    - participant may have other underlying illnesses as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant’s healthcare provider.

    For Cohort 3 only:
    -participant is aged 65 years or older on the day of signing the ICF
    - participant may have underlying illnesses such as hypertension, congestive heart failure, COPD, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant’s healthcare provider.
    - Participantes mayores de 18 años con salud estable en el momento de la vacunación, según el criterio del investigador.
    - Las participantes femeninas deben ser
    a. no estar en edad fértil
    b. en edad fértil y que utilicen un método anticonceptivo eficaz aceptable y que se comprometan a seguir con dicho método anticonceptivo desde la firma del CI hasta 3 meses después de la vacunación del estudio, y que tengan una prueba de embarazo negativa inmediatamente antes de la vacunación del estudio.
    Solo cohorte 1:
    Tener entre 18 y 59 años (inclusive) el día de la firma del DCI.
    Solo cohorte 2 (18-59 años):
    Tener entre 18 y 59 años (inclusive) el día de la firma del DCI.
    Tener una afección cardíaca o pulmonar crónica existente, sin hospitalizaciones ni cambios importantes en la clase de medicación (es decir, medicación nueva o suspendida) en los 30 días anteriores a la selección, y cumple los siguientes criterios (según Falsey et al. [2005])
    a. Enfermedad cardíaca: al menos síntomas de Clase II según la clasificación del Comité de Criterios de la New York Heart Association.
    b. Enfermedad pulmonar: síntomas que restrinjan la actividad o uso de medicamentos a largo plazo.
    - El participante puede tener otras enfermedades subyacentes siempre y cuando sus síntomas y signos sean estables en el momento de la vacunación, y estas condiciones reciban un seguimiento rutinario por parte del proveedor de atención médica del participante.
    Solo cohorte 3:
    Tener 65 años o más el día de la firma del DCI y estar disponible durante todo el estudio.
    Puede tener otras enfermedades subyacentes como hipertensión, insuficiencia cardíaca congestiva, EPOC, diabetes de tipo 2, hiperlipoproteinemia o hipotiroidismo, siempre que sus síntomas y signos sean estables en el momento de la vacunación y estas afecciones reciban un seguimiento rutinario por parte del profesional sanitario del participante.
    E.4Principal exclusion criteria
    1. history of malignancy within 5 years before screening which is not considered cured or with risk of recurrence, other than squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix
    2. known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
    3. abnormal function of the immune system resulting from some clinical conditions, use of corticosteroids, immunomodulating agents or antineoplastic agents
    4. per medical history, participant has chronic active hepatitis B or hepatitis C infection.
    5. per medical history, participant has HIV type 1 or type 2 infection.
    6. history of acute polyneuropathy (eg, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy.
    7. received hematopoietic stem cell transplant in medical history, treatment with immunoglobulins (including monoclonal antibodies for chronic underlying conditions) in the 2 months, immunoglobulins specific to RSV, human metapneumovirus, or parainfluenza viruses in the 12 months, apheresis therapies in the 4 months, or blood products in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study.
    8. history of TTS or heparin-induced thrombocytopenia and thrombosis (HITT).
    9. participant who is pregnant, breastfeeding or planning to become pregnant while enrolled in the study.
    10. received or plans to receive:
    a. Licensed live attenuated vaccines within 28 days before or after planned administration of the study vaccine.
    b. Other licensed (not live) vaccines within 14 days before or after planned administration of the study vaccine.
    11. received or plans to receive a SARS-COV-2 vaccine (licensed or used under EUA):
    a. Live attenuated SARS-COV-2 vaccine within 28 days before or after planned administration of the study vaccine.
    b. Non-live SARS-COV-2 vaccine within 14 days before or after planned administration of the study vaccine.
    c. A viral-vectored SARS-COV-2 vaccine within 28 days prior to randomization or during the study period until 28 days after the study vaccination.
    12. received an RSV vaccine in a previous RSV vaccine study.
    13. received or plans to receive an Ad26-vectored vaccine at any time prior to randomization until 28 days after the last study vaccination, other than a SARS-COV-2 vaccine.
    14. received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the study vaccine or is currently enrolled or plans to participate in another investigational study during this study.
    15. has a serious chronic disorder, eg, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer’s disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    16. has had major surgery within 4 weeks before administration of the study vaccine or will not have recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.
    17.has had major psychiatric illness and/or drug or alcohol abuse which in the investigator’s opinion would compromise the participant’s safety and/or compliance with the study procedures.
    1. Antecedentes de neoplasias en los 5 años anteriores a la selección que no se consideren curadas o con riesgo de recidiva, salvo carcinomas de células escamosas y basales de la piel y carcinoma in situ de cervix.
    2. alergia conocida o sospechada o antecedentes de anafilaxia u otras reacciones adversas graves a las vacunas o sus excipientes (incluyendo específicamente los excipientes de la vacuna del estudio)
    3. función anormal del sistema inmunitario resultante de algunas condiciones clínicas, uso de corticosteroides, agentes inmunomoduladores o agentes antineoplásicos
    4. según la historia clínica, el participante tiene una infección crónica activa por hepatitis B o hepatitis C
    5. por historial médico, el participante tiene infección por VIH tipo 1 o tipo 2.
    6. antecedentes de polineuropatía aguda (por ejemplo, síndrome de Guillain-Barré) o polineuropatía desmielinizante crónica idiopática.
    7. Haber recibido un trasplante de células madre hematopoyéticas en la historia clínica, tratamiento con inmunoglobulinas (incluidos anticuerpos monoclonales para enfermedades crónicas subyacentes) en los 2 meses, inmunoglobulinas específicas para el VRS, metapneumovirus humano o virus de la parainfluenza en los 12 meses, terapias de aféresis en los 4 meses o productos sanguíneos en los 4 meses anteriores a la administración prevista de la vacuna del estudio o tener previsto recibir dicho tratamiento durante el estudio.
    8. Tener antecedentes de SST o trombocitopenia y trombosis inducidas por heparina (TTIH).
    9. Estar embarazada, en periodo de lactancia o tener intención de quedarse embarazada durante la participación en el estudio.
    10. Ha recibido o tiene previsto recibir
    a. Vacunas atenuadas vivas autorizadas en los 28 días anteriores o posteriores a la administración programada de la vacuna del estudio.
    b. Otras vacunas autorizadas (no vivas) en los 14 días anteriores o posteriores a la administración programada de la vacuna del estudio.
    11. Ha recibido o tiene previsto recibir una vacuna contra el SARS-COV-2 (autorizada o utilizada en el marco de la EUA):
    a. Vacuna atenuada viva contra el SARS-COV-2 en los 28 días anteriores o posteriores a la administración programada de la vacuna del estudio.
    b. Vacuna inactivada contra el SARS-COV-2 en los 14 días anteriores o posteriores a la administración programada de la vacuna del estudio.
    c. Una vacuna de vectores virales contra el SARS-COV-2 dentro de los 28 días anteriores a la aleatorización o durante el período de estudio hasta 28 días después de la vacunación del estudio
    12. Haber recibido una vacuna contra el VRS en un estudio previo de vacunas contra el VRS.
    13. Haber recibido o tener previsto recibir una vacuna con vector Ad26 en cualquier momento antes de la aleatorización hasta 28 días después de la última vacunación del estudio, que no sea una vacuna contra el SARS-COV-2.
    14. Haber recibido un fármaco en investigación o haber utilizado un dispositivo médico invasivo en investigación en los 30 días anteriores, o haber recibido una vacuna en investigación en los 6 meses anteriores a la administración prevista de la vacuna del estudio, o está actualmente inscrito o tiene previsto participar en otro estudio en investigación durante este estudio.
    15. Tiene un trastorno crónico grave, por ejemplo, enfermedad renal en fase terminal con o sin diálisis, enfermedad cardíaca clínicamente inestable, enfermedad de Alzheimer, o tiene cualquier condición para la cual, en opinión del investigador, la participación no redundaría en el interés del participante (por ejemplo, si afectara a su bienestar) o que podría impedir, limitar o confundir las evaluaciones especificadas en el protocolo.
    16. Haber tenido una cirugía mayor dentro de las 4 semanas anteriores a la administración de la vacuna del estudio o no haberse recuperado de la cirugía, o tiene prevista una cirugía mayor durante el tiempo que se espera que el participante participe en el estudio.
    17. Haber padecido una enfermedad psiquiátrica grave y/o abuso de drogas o alcohol que, en opinión del investigador, podría comprometer la seguridad del participante y/o el cumplimiento de los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1. Solicited local (injection site) and systemic AEs for 7 days after vaccination
    2. Unsolicited AEs for 28 days after vaccination
    3. SAEs and AESIs until 6 months after vaccination
    4. pre-F ELISA antibody titers at 14 days after vaccination in the Immuno Subset
    5. pre-F ELISA antibody titers at 14 days after vaccination in the Immuno Subset
    1. EA locales (en el lugar de la inyección) y sistémicos solicitados durante los 7 días posteriores a la vacunación
    2. EA no solicitados durante los 28 días posteriores a la vacunación
    3. EAS y EAEI hasta 6 meses después de la vacunación
    4. Títulos de anticuerpos pre-F ELISA a los 14 días de la vacunación en el subconjunto inmunológico
    5. Títulos de anticuerpos ELISA pre-F a los 14 días de la vacunación en el subconjunto inmunológico
    E.5.1.1Timepoint(s) of evaluation of this end point
    - 7, 14, 28 days after vaccination
    - SAEs and AESIs until 6 months after vaccination
    - 7, 14, 28 días después de la vacunación
    - EAS y EAEI hasta 6 meses después de la vacunación
    E.5.2Secondary end point(s)
    1. pre-F ELISA antibody titers at 6 months after vaccination
    2. Pre-F ElISA seroresponse rate at Day 15
    1. Títulos de anticuerpos pre-F ELISA a los 6 meses de la vacunación
    2. Tasa de respuesta serológica pre-F ELISA en el día 15.
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 15 and 6 months after vaccination
    día 15 y 6 meses después de la vacunación
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Reactogenicity and Immunogenicity
    Reactogenicidad e inmunogenicidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Belgium
    Germany
    Spain
    Sweden
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state680
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 837
    F.4.2.2In the whole clinical trial 930
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    N/A
    NO APLICA
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 10:38:20 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA